Dophi

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref SS-RFAS2-0705

by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Identity

Trade Name: RF Ablation Electrode Kits EUDAMED
Dophi FDA UDI
Generic Name: Radio-frequency ablation system FDA UDI
Device Name: Radiofrequency Ablation System EUDAMED
Radio Frequency Electrode Kits FDA UDI
Model / Reference: SS-RFAS2-0705 EUDAMEDFDA UDI
Description: Radio Frequency Electrode Kits FDA UDI

Identifiers

Primary DI / UDI-DI: 16972304750138 EUDAMEDFDA UDI
Basic UDI-DI: 69723047500016P EUDAMED
510(k) Number: K190052 FDA UDI
FDA Product Code: GEI FDA UDI
EMDN Code: K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
GMDN Term: Radio-frequency ablation system FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Market of Registration: Finland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radio-frequency ablation system

Dophi by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radio-frequency ablation system.

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Sources (2)

FDA UDI 94658086-45da-4ae9-8830-94f58978efdb 34 fields · synced Jul 12, 2026
EUDAMED 6ed7b16d-3e42-4fe4-878d-09bc7e539708 61 fields · synced Jul 12, 2026

Dophi

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (2)